Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-28 @ 8:47 AM
Study NCT ID:
NCT04670757
Status:
COMPLETED
Last Update Posted:
2022-05-16
First Post:
2020-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetics of JAK/ROCK Inhibitor in Healthy Volunteers
Sponsor:
Celon Pharma SA
Organization:
Study Overview
Official Title:
One Centre, Single Ascending Dose and Double Blind Multiple Ascending Dose, Safety and Pharmacokinetics Phase I Study of CPL409116 Compound in Healthy Volunteers.
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the following clinical trial is to determine safety an pharmacokinetic parameters in healthy volunteers after oral administration of Janus kinases and Rho-kinases inhibitor (JAK/ROCKi), called CPL409116.Janus kinase (JAK) inhibitors are a new class of small molecule drugs that modulate inflammatory pathways by blocking one or more JAK receptors. In recent years, JAK inhibitors have emerged as a new option for the treatment of various inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis, skin disorders and others. CPL409116 inhibits JAK1 and JAK3 with less inhibitory activity against JAK2 and Tyk2. Inhibition of these kinases decreases inflammatory cytokine release which in turn decreases lymphocyte activation and proliferation. Moreover, CPL409116 blocks Rho-kinases (ROCKs), which are involved in diverse cellular processes including actin cytoskeleton organization, cell adhesion and motility, proliferation, apoptosis as well as smooth muscle contraction. ROCKs signalling is one of the major pathways implicated in the pathogenesis of cardiovascular, renal as well as fibrotic diseases. However recent data indicate their role in immune cell regulation and inflammatory disease development. CPL409116 was designed predominantly for the therapy of immune-related diseases: rheumatoid arthritis, psoriasis and because antifibrotic therapies are needed. Dual inhibition of JAK/ROCK kinases may be beneficial for patients suffering from fibrotic complications of inflammatory disease.
Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease characterised by persistent joint inflammation leading to loss of joint function as well as cartilage and bone damage. Chronic, progressive course of the disease results in disability, reduced quality of life, as well as higher comorbidity and mortality rates. It is well documented that JAK kinases play a pivotal role in cytokine receptor signalling to phosphorylate and activate signal transducer and activator of transcription (STAT) proteins. Several of these JAK-controlled cytokine receptor pathways are immediately involved in the initiation and progression of RA pathogenesis. Cytokines promote autoimmunity, maintain chronic inflammatory synovitis and drive the destruction of joint tissue. In consequence on the basis of the preclinical study results the IMP with the active ingredient CPL409116 has been classified as a good clinical candidate for the treatment of RA.
Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease characterised by persistent joint inflammation leading to loss of joint function as well as cartilage and bone damage. Chronic, progressive course of the disease results in disability, reduced quality of life, as well as higher comorbidity and mortality rates. It is well documented that JAK kinases play a pivotal role in cytokine receptor signalling to phosphorylate and activate signal transducer and activator of transcription (STAT) proteins. Several of these JAK-controlled cytokine receptor pathways are immediately involved in the initiation and progression of RA pathogenesis. Cytokines promote autoimmunity, maintain chronic inflammatory synovitis and drive the destruction of joint tissue. In consequence on the basis of the preclinical study results the IMP with the active ingredient CPL409116 has been classified as a good clinical candidate for the treatment of RA.
Detailed Description:
The following clinical trial consists of two phases IA and IB. Approximately 68 volunteers who meet all the inclusion and none of the exclusion criteria are going to be enrolled into the study. Phase IA (approx. 24 male and female volunteers) is to evaluate safety and tolerability after single oral administration of the Investigational Medicinal Produkt (IMP) to healthy volunteers. Additional cohort (approx 12 healthy volunteers) is going to be included in the phase IA of the study to assess the food effect on CPL409116 compound's bioavailability after one dose of single oral IMP administration. There are to be two treatments periods for this cohort: fasted and fed. Phase IB (approx. 32 male and female volunteers) is to evaluate safety and tolerability after two weeks of oral administration of IMP to healthy volunteers.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: